Abstract: A distal tip assembly for an elongate medical device having an axis comprises a shaft having a proximal end portion, a distal end portion, a wall, and a central lumen extending axially between said proximal end portion and said distal end portion. The distal tip assembly further comprises a position sensor disposed in an outer sleeve such that the sensor can shift relative to the sleeve. The sleeve is disposed at least in part in the wall and is substantially fixed thereto.

Abstract: Actuators for steerable medical devices are disclosed that not only deflect or steer a portion of a medical device (e.g., a distal portion of a catheter shaft), but also include mechanisms for actively returning the deflected portion of the medical device to an initial configuration (e.g., straight or substantially straight). These active return-to-straight mechanisms may return a catheter shaft from a deflected configuration to a substantially straight configuration throughout a medical procedure, may employ one or more tension members extending along the catheter shaft, and may comprise a gross return actuator and a fine return actuator. For example, the gross return actuator may be configured to partially reverse the deflection of the distal portion of the catheter; and the fine return actuator may be configured to continue reversing the deflection. The gross return actuator may automatically trigger or actuate (mechanically or electromechanically) the fine return actuator.

Abstract: An electrophysiology catheter for use with a steerable introducer sheath includes a flexible catheter body having a proximal end and a distal end and at least one hollow elongate tip electrode disposed at the distal end of the catheter body. The hollow elongate tip electrode includes a sidewall having at least one elongate gap that provides flexibility allowing the tip electrode to bend relative to a longitudinal axis of the catheter body. The catheter body is an independent, non-steerable structure, and can be moved via movement of the steerable introducer through which it is introduced into a patient.

Abstract: A circuit (10, 110, 210) configured for connecting an electrode (28, 126, 228) to a catheter or sheath is disclosed. The circuit (10, 110, 210) includes a member (12, 112, 212) having a longitudinal axis (14, 214) and configured to extend along at least a portion of the length of the catheter or sheath. The circuit (10, 110, 210) further includes a trace (16, 116, 230) printed on the member (12, 112, 212), where the trace (16, 116, 230) includes at least a longitudinal segment (18, 118) extending generally along at least a portion of the longitudinal axis (14, 214) and a transverse segment (20, 120) extending generally transverse to the longitudinal axis (14, 214). In an embodiment, the circuit further includes a pad (26, 126, 226) integral with and extending from the (10, 110, 210) proximal the transverse segment (20, 120) of the trace (16, 116, 230). A catheter or sheath assembly comprising the circuit (10, 110, 210) and an electrode (28, 126, 228) connected to the circuit (10, 110, 210) is also disclosed.

Abstract: A medical device is provided comprising a shaft comprising a first segment and a second segment. The first segment is configured to buckle upon application of a first critical force. The second segment includes an outer surface and an inner surface and is configured to buckle upon application of a second critical force. The second critical force is lower than the first critical force. The medical device further comprises a coil disposed radially inwardly of the inner surface of the second segment.

Abstract: A magnetically-guided catheter includes a tip positioning magnet in the distal electrode assembly configured to interact with externally applied magnetic fields for magnetically-guided movement. A magnetically-guided mapping catheter includes an electrically-conductive capsule in the form of a casing that includes a distal ablation surface and isolates the positioning magnet from bio-fluids to prevent corrosion. An open irrigation ablation catheter includes an isolated manifold that isolates the positioning magnet from contact with irrigation fluid to prevent corrosion. A device and method to manufacture a magnetically driven electrode-catheter with flexible tethering includes one or more KEVLAR® fibers, distributed centrally or peripherally within a catheter shaft and oriented longitudinally, transversely, angularly or spirally.

Abstract: The present invention is a catheter actuation handle for deflecting a distal end of a tubular catheter body, the handle including an auto-locking mechanism. The handle comprises upper and lower grip portions, an actuator, and an auto-locking mechanism. The auto-locking mechanism is adapted to hold a deflected distal end of the catheter in place without input from the operator. When the distal end of the catheter is deflected from its zero position, it typically will seek a return to its zero position, and as a result exerts a force on the actuator. The auto-locking mechanism acts by providing a second force that resists this force from the distal end and holds the distal end in place. As a result, the operator does not need to maintain contact with the buttons to maintain the distal end 18 in a set position once placed there by actuating the actuator.

Abstract: A hemostasis valve has a housing having proximal and distal ends defining proximal and distal openings configured for passage of a medical device therethrough. The housing further defines a cavity between the proximal and distal ends. One or more rollers are received within the cavity and define end sections and a central section having a smaller diameter than the end sections. Sleeves are disposed about the rollers and are elastically deformable to form a fluid seal around the device. The sleeves each assume a first form when the device is absent from the cavity wherein a radially inner surface of the sleeve is located at a first distance from the central section of a roller and a second form when the device is present in the cavity wherein the surface is located at a second distance, less than the first distance, from the central section of the roller.

Abstract: Catheter shaft handles and deflection actuators are disclosed. The actuators include at least one pull wire guide wall and a means for anchoring the proximal portion of a pull wire or of a fiber attached to a pull wire. Each actuator is pivotable relative to the catheter handle housing, and may comprise at least one boss for pivoting the actuator relative to the catheter handle housing. The actuators transfer rotational motion based upon user input on a boss into longitudinal motion of a pull wire. The actuators may include a tensioning mechanism comprising a tension adjustment pin and a pin block, wherein the tension adjustment pin is rotatably attached to the pin block to enable adjustment of tension in a pull wire (e.g., during assembly of the catheter handle).

Abstract: An electrode support structure assembly is provided comprising an electrode support structure including a plurality of splines. Each of the plurality of splines can have a proximal end portion and a distal end portion. The assembly further comprises a first element defining an axis and comprising an outer surface. The outer surface comprises a plurality of slots configured to receive the distal end portion of each of the plurality of splines. The first element is configured such that the distal end portion of each of the plurality of splines may move with respect to each slot. In accordance with some embodiments, the distal end portion of each of the plurality of splines comprises a section configured for engagement with the first element, wherein the section comprises a shoulder.

Abstract: A deflectable catheter shaft section is disclosed comprising an elongated body extending along a longitudinal axis and comprising a distal end and a proximal end; and a plurality of lumens extending along the longitudinal axis of the elongated body, wherein at least one of the lumens is abutting at least another one of the lumens. A catheter comprising the deflectable catheter shaft section and a method of manufacturing the deflectable catheter shaft section are also disclosed. A catheter incorporating a deflectable catheter shaft section can further comprise first and second compression coils disposed over pull wires located within the catheter, wherein the compression coils are unattached to the catheter or components thereof, but can be constrained by a shaft coupler at a distal end of each of the compression coils and by at least a portion of a handle assembly at a proximal end of each of the compression coils.

Abstract: A magnetically-guided catheter 100 includes a tip positioning magnet in the distal electrode assembly configured to interact with externally applied magnetic fields for magnetically-guided movement. A magnetically-guided mapping catheter 100 includes an electrically-conductive capsule in the form of a casing 146 that includes a distal ablation surface and isolates the positioning magnet from bio-fluids to prevent corrosion. An open irrigation ablation catheter includes an isolated manifold that isolates the positioning magnet from contact with irrigation fluid to prevent corrosion.

Abstract: A distal tip assembly for an elongate medical device having an axis comprises a shaft having a proximal end portion, a distal end portion, a wall, and a central lumen extending axially between said proximal end portion and said distal end portion. The distal tip assembly further comprises a position sensor disposed in an outer sleeve such that the sensor can shift relative to the sleeve. The sleeve is disposed at least in part in the wall and is substantially fixed thereto.

Abstract: A magnetically-guided catheter includes a tip positioning magnet in the distal electrode assembly configured to interact with externally applied magnetic fields for magnetically-guided movement. A magnetically-guided mapping catheter includes an electrically-conductive capsule in the form of a casing that includes a distal ablation surface and isolates the positioning magnet from bio-fluids to prevent corrosion. An open irrigation ablation catheter includes an isolated manifold that isolates the positioning magnet from contact with irrigation fluid to prevent corrosion.

Abstract: Catheter ultrasound systems including a sheath, a handle, a sheath lumen, and an ultrasound catheter disposed within the lumen of the sheath with ultrasound elements capable of visualizing anatomical regions. The handle allowing the ultrasound catheter to rotate with respect to the sheath using a rotation adjustment knob within the handle or alternatively an separate manipulation handle attached to the proximal end of the ultrasound catheter. The sheath, ultrasound catheter, or both may also include one or more electrodes or other location sensor for both orienting the ultrasound element as well as for diagnostic purposes.

Abstract: A robotic catheter device cartridge may include a finger or a slider block generally disposed in a channel and engaged with a steering wire. The steering wire may control movement of a component having the steering wire engaged thereto when the finger or the slider block is linearly driven in a predetermined direction. The cartridge may be a transseptal cartridge having a transseptal needle connected thereto, a catheter cartridge having a catheter connected thereto, or a sheath cartridge having a sheath connected thereto.

Abstract: An apparatus for deflecting a distal portion of a catheter, a sheath, a medical device, or other flexible elongate member may generally include a handle portion, a pair of adjusting knobs, and deflection wires. The adjusting knobs may be rotatably coupled to the handle portion and operably coupled to the deflection wires. The deflection wires may be in further communication with the distal portion of the flexible elongate member. Rotation of the adjustment knobs may translate or otherwise displace particular deflection wires with respect to the rest of the flexible elongate member, thereby causing the distal portion of the flexible elongate member to deflect. Further, the deflection wires may be oriented such that the distal portion of the flexible elongate member may be deflected in a multitude of directions.

Abstract: An electrode support structure assembly is provided comprising an electrode support structure including a plurality of splines. Each of the plurality of splines can have a proximal end portion and a distal end portion. The assembly further comprises a first element defining an axis and comprising an outer surface. The outer surface comprises a plurality of slots configured to receive the distal end portion of each of the plurality of splines. The first element is configured such that the distal end portion of each of the plurality of splines may move with respect to each slot. In accordance with some embodiments, the distal end portion of each of the plurality of splines comprises a section configured for engagement with the first element, wherein the section comprises a shoulder.

Abstract: A method of manufacturing a catheter assembly generally includes providing a catheter shaft having an outer layer and an inner reinforcing layer; removing at least a portion of the outer layer from a length of the distal end of the catheter shaft in order to expose a distal segment thereof; providing an inner jacket segment; axially engaging the inner jacket segment with an interior surface of the distal segment of the catheter shaft; providing an outer jacket segment around at least the exposed exterior region of the distal segment of the catheter shaft; and bonding the distal segment of the catheter shaft to the inner jacket segment and the outer jacket segment.